Co-Diagnostics Receives CE Mark for Tuberculosis Test Kit

July 25, 2018 06:30 AM Eastern Daylight Time

SALT LAKE CITY--(BUSINESS WIRE)--Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics
company with a unique, proprietary platform for the development of
molecular diagnostic tests, announced today that its Logix Smart™ MTB
Test has obtained CE mark approval, the principle regulatory clearance
allowing the test to be sold as an in vitro diagnostic (“IVD”)
for the diagnosis of tuberculosis in European Union states and other
markets that accept a CE-IVD mark as valid regulatory approval.

The World Health Organization (WHO) confirms that as of 2016, the latest
year for which data is available, tuberculosis (TB) is one of the top 10
causes of death globally, proving fatal to 1.7 million people, and is
the leading killer of individuals infected with HIV. Prompt and accurate
TB treatment is also believed to have saved 53 million lives between
2000 and 2016, with a success rate as high as 83% in 2015. However,
symptoms of tuberculosis may be mild or non-existent early on, and many
affected people seek a diagnosis too late after the disease has
advanced, which is then more difficult to treat and more likely to be
fatal. In some regions, cost prohibits residents from seeking a
tuberculosis diagnosis.

Dwight Egan, Chief Executive Officer of Co-Diagnostics, remarked, “This
granting of this CE mark represents a milestone not only for
Co-Diagnostics, but for all individuals in need of an affordable,
high-quality TB diagnostic in areas not blessed with wealth or access to
philanthropic subsidies. Our proprietary design platform and CoPrimer™
technology, on which this test was built, are now also being used to
design tests for HIV and multi-drug resistant tuberculosis (“MDR-TB”).
These diagnostics are in high demand where TB is prevalent and will
further augment the tools available to people in those areas, in
addition to expanding the Company’s footprint there as well.”

Co-Diagnostics will manufacture its Logix Smart MTB test in the
Company’s ISO 13485:2016 facility for the development and manufacture of
IVD Medical Devices located in Utah, USA, and at this time is not
seeking approval by the FDA for sale in the United States due to the low
domestic rate of tuberculosis incidents.

The CE mark confirms that the test meets the Essential Requirements of
the European Community’s In-Vitro Diagnostic Medical Device Directive
(IVDD 98/79/EC). The Logix Smart MTB Test detects DNA of mycobacteria
tuberculosis (MTB) complex members and functions via real-time
polymerase chain reaction (PCR) to detect and amplify the IS6110
and MPB64 regions of the MTB genome.

About Co-Diagnostics, Inc.:

Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics
company with a proprietary diagnostic testing technology and development
platform that intends to manufacture and sell reagents used for
diagnostic tests that function via the detection and/or analysis of
nucleic acid molecules (DNA or RNA), and license the use of its platform
to other non-competing developers.

Forward-Looking Statements:

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